HTG Molecular Diagnostics Reports Fourth Quarter and Full Year 2016 Results

March 23, 2017 at 4:04 PM EDT
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TUCSON, Ariz., March 23, 2017 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM), a provider of instruments, reagents and services for molecular profiling applications, today reported financial results for the fourth quarter and year ended December 31, 2016.

Recent Accomplishments & Highlights:

  • Signed a development, manufacturing and commercialization agreement with a wholly owned affiliate of QIAGEN, N.V.

    •  QIAGEN North American Holdings also made a minority investment in HTG’s common stock

    •  Completed technical feasibility assay for QIAGEN GeneReader next-generation sequencing platform

  • Obtained CE marking for the HTG EdgeSeq ALKPlus Assay for commercialization of the assay as an in vitro diagnostic (IVD) in the European Union

  • Announced availability of new direct sequencing chemistry and initial DNA mutation assay as a service offering in the company’s VERI/O laboratory

  • Achieved revenue of $1.5 million for the fourth quarter of 2016 compared to $1.2 million in Q4 2015

    •  Service revenue increased to $381,000 in the fourth quarter of 2016 from $33,000 in Q4 2015

  • Achieved revenue of $5.1 million for the year ended December 31, 2016 compared to $4.0 million for the year ended December 31, 2015

    •  Service revenue increased to $2.4 million in 2016 from $184,000 in 2015

“In 2016, we believe HTG made significant strides in customer adoption and building a solid platform for long-term growth,” said TJ Johnson, HTG’s President and CEO.

Fourth Quarter 2016 Financial Results:                                                                                                                                                                     

Revenue for the fourth quarter of 2016 was $1.5 million. Net loss from operations was $5.2 million for the fourth quarter of 2016, compared to $5.3 million for the fourth quarter of 2015. Net loss per share was $(0.76) for the fourth quarter of 2016 and $(0.83) for the fourth quarter of 2015.

Full Year 2016 Financial Results:

Revenue for the year ended December 31, 2016 was $5.1 million. Net loss from operations for the year ended December 31, 2016 was $24.3 million, compared to $18.9 million for the year ended December 31, 2015. Net loss per share was $(3.66) for the year ended December 31, 2016 and $(5.03) for the year ended December 31, 2015. HTG ended 2016 with $11.8 million in total cash and investments, including $7.5 million in cash and equivalents and $4.3 million in short term available-for-sale investments, and current liabilities of approximately $10.0 million plus an additional $14.0 million in long-term liabilities.

Conference Call

HTG will host an investment community conference call today beginning at 5:00 p.m. ET. Individuals interested in listening to the conference call may dial (866) 394-4225 for domestic callers, or (678) 509-7535 for international callers, conference ID 91525538, or access the webcast on the investor relations section of the Company’s website at: www.htgmolecular.com. The webcast will be available on the Company’s website for 90 days following the completion of the call.

About HTG:

Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013, the company commercialized its first instrument platform and a portfolio of RNA assays that leveraged HTG's original proprietary nuclease protection chemistry. Continuous improvement led to the 2014 launch of the company’s HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our growth prospects, and strategic priorities. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with our ability to enter into new collaborations with Pharma customers, risks associated with our ability to obtain regulatory clearances or approvals in the United States and other jurisdictions to market panels for diagnostic purposes, our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; requirements for additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Annual Report on Form 10-K for the year ended December 31, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

-Financial tables follow-


HTG Molecular Diagnostics, Inc.  
Statements of Operations  
   
                                 
    Three Months Ended December 31,     Years Ended December 31,  
    2016     2015     2016     2015  
    (Unaudited)                  
Revenue:                                
Product   $ 1,076,560     $ 1,182,287     $ 2,759,942     $ 3,532,028  
Service     381,221       33,466       2,372,788       183,758  
Other     —       —       —       325,789  
Total revenue     1,457,781       1,215,753       5,132,730       4,041,575  
Cost of revenue     1,234,429       796,921       4,135,884       3,335,511  
Gross margin     223,352       418,832       996,846       706,064  
                                 
Operating expenses:                                
Selling, general and administrative     4,083,832       4,111,249       17,427,777       14,994,410  
Research and development     1,384,503       1,650,709       7,900,311       4,601,718  
Total operating expenses     5,468,335       5,761,958       25,328,088       19,596,128  
Operating loss     (5,244,983 )     (5,343,126 )     (24,331,242 )     (18,890,064 )
Loss from change in stock warrant valuation     —       —       —       (239,683 )
Interest expense, net     (425,649 )     (348,443 )     (1,755,053 )     (1,633,616 )
Loss on settlement of convertible debt     —       —       —       (705,217 )
Other     3,410       2,105       56,863       80,978  
Net loss before income taxes     (5,667,222 )     (5,689,463 )     (26,029,432 )     (21,387,602 )
Income taxes     5,859       10,189       10,118       10,189  
Net loss     (5,673,081 )     (5,699,652 )     (26,039,550 )     (21,397,791 )
Accretion of redeemable convertible preferred stock discount, issuance costs and dividends     —       —       —       (1,328,594 )
Net loss attributable to common stockholders   $ (5,673,081 )   $ (5,699,652 )   $ (26,039,550 )   $ (22,726,385 )
                                 
Net loss per share attributable to common stockholders, basic and diluted   $ (0.76 )   $ (0.83 )   $ (3.66 )   $ (5.03 )
Shares used in computing net loss per share attributable to common stockholders, basic and diluted     7,488,842       6,840,918       7,113,075       4,518,499  
                                 
   


HTG Molecular Diagnostics, Inc.  
Balance Sheets  
                 
                 
    December 31,  
    2016     2015  
Assets                
Current assets:                
Cash and cash equivalents   $ 7,507,659     $ 3,293,983  
Short-term investments available-for-sale, at fair value     4,304,901       28,201,507  
Accounts receivable     1,377,441       716,246  
Inventory, net     1,511,053       2,201,301  
Prepaid expenses and other     433,328       445,217  
Total current assets     15,134,382       34,858,254  
                 
Long-term investments available-for-sale, at fair value     —       2,603,901  
Deferred offering costs     49,630       —  
Property and equipment, net     3,270,197       1,932,213  
Total assets   $ 18,454,209     $ 39,394,368  
                 
                 
Liabilities and stockholders' equity (deficit)                
Current liabilities:                
Accounts payable   $ 761,663     $ 724,805  
Accrued liabilities     1,670,286       1,915,268  
Deferred revenue     335,659       47,476  
NuvoGen obligation     604,751       543,750  
Term loan     6,389,782       3,059,068  
Other current liabilities     258,850       29,243  
Total current liabilities     10,020,991       6,319,610  
Term loan payable - non-current, net of discount and debt issuance costs     5,389,137       7,737,586  
NuvoGen obligation - non-current, net of discount     8,017,356       8,415,122  
Other     619,587       28,652  
Total liabilities     24,047,071       22,500,970  
Commitments and Contingencies                
Total stockholders’ equity (deficit)     (5,592,862 )     16,893,398  
Total liabilities and stockholders' equity (deficit)   $ 18,454,209     $ 39,394,368  
                  
Contact:

Westwicke PartnersJamar Ismail
Phone: (415) 513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostic
Phone: (520) 547-2827 x130
Email: tjjohnson@htgmolecular.com

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HTG Molecular Diagnostics, Inc.